BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD?

    MDR report key: 3242332 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04928
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K955396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER 18 YEARS OF AGE. (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IVC FILTER PLACEMENT PROCEDURE DEPLOYMENT ISSUES OCCURRED. AN OTW GREENFIELD FILTER WAS ADVANCED AND DEPLOYED IN THE VENA CAVA ARTERY; HOWEVER, THE LEGS WERE CROSSED AND DID NOT ALLOW THE FILTER TO FULLY OPEN. THE PHYSICIAN USED A UNSPECIFIED BALLOON TO COMPLETE THE DEPLOYMENT OF THE FILTER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343099 GREENFIELD? FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001505010 15868739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention